Navigation Links
YM BIOSCIENCES PROVIDES EU REGULATORY UPDATE
Date:12/5/2008

MISSISSAUGA, ON, Dec. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today reported that Oncoscience AG, the European licensee of nimotuzumab from YM's subsidiary, CIMYM BioSciences Inc., has withdrawn its application to the European Medicines Agency (EMEA) for marketing authorization of nimotuzumab. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

The application for the marketing authorization for nimotuzumab was submitted to the EMEA on October 4th, 2007. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its official letter Oncoscience AG states that the withdrawal of the application was made 'because it was not able to adequately address the concerns of the CHMP regarding the quality and efficacy of the medicine within the required time schedule'.

"The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma. This analysis in no manner reflects on the overall efficacy of nimotuzumab, which already has been approved for marketing in twelve countries with efficacy demonstrated in numerous indications," said David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that Oncoscience AG withdrew its application in anticipation of a later resubmission as this application was based on a very small sample that was not prospectively studied. We note that this withdrawal is consistent with actions taken by numerous large and development stage pharmaceutical companies under similar circumstances and we believe it was the correct means for managing th
'/>"/>

SOURCE YM BioSciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. CeloNova BioSciences Commercializes CATANIA(TM) Coronary Stent With NanoThin Polyzene(R)-F in Europe and Middle East
2. DuPont Applied BioSciences Selects MBI to Collaborate on Process Development and Scale-Up for New Bio-based Product
3. Ellen McDonald Joins Regado Biosciences as Senior Vice President of Business Operations and Chief Business Officer
4. Frost & Sullivan Recognizes Martek Biosciences for Unique and Customer-Focused Strategies With Customer Value Enhancement Award
5. Regado Biosciences to Present at the Piper Jaffray Health Care Conference on Tuesday, December 2, 2008
6. Sangamo BioSciences to Webcast Annual Investor and Analyst Briefing and Presentation at Piper Jaffray Health Care Conference
7. Cyntellect Appoints Former BD Biosciences Executive Andre Lubarsky as Director of Sales - North America
8. Neurocrine Biosciences to Present at the 20th Annual Piper Jaffray Health Care Conference
9. Sangamo BioSciences Appoints Paul Cleveland to Its Board of Directors and Chair of Audit Committee
10. BBM Announces Offer to Acquire YM BioSciences Inc.
11. Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... July 11, 2014 /PRNewswire-iReach/ -- Maxim Peptide, a website ... are used solely in scientific experiments, is currently celebrating ... in business, Maxim Peptide, which was created by the ... new and updated website that now features a special ... been updated with fascinating articles about peptide research, including ...
(Date:7/11/2014)... Research ( http://www.bccresearch.com ) reveals in its new report, ... MARKETS , the global market for digital polymerase chain ... This is estimated to grow to $490 billion in ... of 28.6%. , New digital PCR technology has created ... broader PCR field. The opportunities presented by this technology ...
(Date:7/11/2014)... 11, 2014  Researchers have pioneered a revolutionary ... new technology, called Virtual Finger, allows scientists to ... neurons and synapses using the flat surface of ... 3D imaging studies orders of magnitude more efficient, ... level across many areas of experimental biology. The ...
(Date:7/10/2014)... 2014 Product and process impurities ... abundance and are often “lost in the noise,” ... Join presenters Dr. Rowel Tobias, Senior Scientist, Protein ... Head of Quality at Nanotherapeutics, Inc., to lear ... speed detection and quantitation while achieving the required ...
Breaking Biology Technology:Maxim Peptide Celebrates Second Anniversary Online with an Updated Website and Special Deals Section 2Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 2Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 3Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 2Virtual Finger Enables Scientists To Navigate And Analyze 3D Images Of Complex Biological Structures 3Novel Ms Techniques Speed Detection of Biopharmaceutical Product and Process Impurities, New Webinar Hosted by Xtalks 2
... Inc. (Nasdaq: ADLS ), a biopharmaceutical company ... drugs in the,therapeutic areas of infection, cancer and ... third quarter ended September 30,2007. (Logo: ... three months ended September 30, 2007 was $5.8,million ...
... 14 Micromet, Inc.,(Nasdaq: MITI ) ("Micromet" ... antibodies for the treatment of cancer,inflammation and autoimmune ... the Company appointed Joseph P. Slattery as a ... audit committee. The appointment will be,effective as of ...
... Results and Business Update - ... a.m. Eastern Time -, OAKLAND, Calif., Nov. 14 ... of mechanical circulatory,support systems, will report its third quarter 2007 ... business update in a,teleconference at 8:30 a.m. Pacific / 11:30 ...
Cached Biology Technology:Advanced Life Sciences Announces Third Quarter 2007 Financial Results 2Advanced Life Sciences Announces Third Quarter 2007 Financial Results 3Advanced Life Sciences Announces Third Quarter 2007 Financial Results 4Advanced Life Sciences Announces Third Quarter 2007 Financial Results 5Advanced Life Sciences Announces Third Quarter 2007 Financial Results 6Advanced Life Sciences Announces Third Quarter 2007 Financial Results 7Advanced Life Sciences Announces Third Quarter 2007 Financial Results 8Advanced Life Sciences Announces Third Quarter 2007 Financial Results 9Micromet, Inc. Elects Joseph P. Slattery to Board of Directors 2Micromet, Inc. Elects Joseph P. Slattery to Board of Directors 3Micromet, Inc. Elects Joseph P. Slattery to Board of Directors 4
(Date:7/10/2014)... , July 2, 2014  Unisys Corporation,s (NYSE: ... , Unisys Nederland N.V., today announced that it has been ... implement and manage a new Basic Provision Biometrics solution for ... Unisys won the contract with a solution based on ... software. The term of the contract is up to seven ...
(Date:7/10/2014)... , July 3, 2014 ... Market by Type (Swipe And Area), Material (Optical Prism, ... Healthcare, Commercial Security and Banking & Finance), and Geography ... published by MarketsandMarkets, the global Fingerprint Sensors Market is ... a high CAGR of 16.8% from 2014 to 2020. ...
(Date:7/10/2014)... , July 7, 2014 ... Market Research "Electronic Access Control Systems Market Global Forecast, ... 2019," the global Electronic Access Control systems market was ... expected to grow at a CAGR of 12.6% from ... USD 31,187.8 million in 2019. Browse the ...
Breaking Biology News(10 mins):Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 2Unisys Delivers New Basic Provision Biometrics Solution to Dutch Custodial Institutions Service 3Fingerprint Sensors Market worth $14.35 Billion by 2020 2Fingerprint Sensors Market worth $14.35 Billion by 2020 3Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 2Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 3Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 4Electronic Access Control Systems Market is Expected to Reach USD 31.2 Billion Globally in 2019: Transparency Market Research 5
... WEST LAFAYETTE, Ind. - Honeybee populations have been in ... have identified one of the factors that cause bee ... dead in and around hives from several apiaries over ... insecticides, which are commonly used to coat corn and ...
... University of Illinois researchers have shown that by ... of metal nanoantennas, these nano-scale structures allow for ... particles. "Nanoantennas are extremely popular right ... optical fields in small areas," explained Kimani Toussaint, ...
... Calif. Scientists have long seen evidence of social behavior among ... the sea. Dolphins frolic together, lions live in packs, and ... the insects. And, right under our feet, it appears that ... the soil. Until recently, it was unknown how the worms ...
Cached Biology News:Researchers: Honeybee deaths linked to seed insecticide exposure 2Researchers: Honeybee deaths linked to seed insecticide exposure 3Optical nanoantennas enable efficient multipurpose particle manipulation 2Worm seeks worm: Caltech researchers find chemical cues driving aggregation in nematodes 2Worm seeks worm: Caltech researchers find chemical cues driving aggregation in nematodes 3
Taq DNA Polymerase (T. aquaticus), 250 units. For PCR and other procedures requiring DNA polymerase activity at elevated temperatures. Category: Nucleotides & Enzymes & Biochemicals, Modifying Enzyme...
... • Enzyme concentration - 5 units/µL ... in higher yields ,• Leaves an ... thermostable DNA polymerase which exhibits very high ... biology applications. To ensure the quality of ...
Recombinant DNA polymerase from Thermus aquaticus expressed in E. coli; 5 units/L; 1 tube of 1, 000 units enzyme/tube w/Buffer II and MgCl2...
... • Enzyme concentration - 5 units/µL ,• ... higher yields ,• Leaves an 'A' overhang ... polymerase which exhibits very high activity in ... To ensure the quality of the enzyme, ...
Biology Products: